Safety and Efficacy of Freezing and Thawing of Human Eggs in Assisted Reproductive Technology - Full Text View

Sponsored by:	ViaCell
Information provided by:	ViaCell
ClinicalTrials.gov Identifier:	NCT00451009

Purpose

The purpose of this study is to determine the effectiveness of the ViaCyte media for freezing and thawing human eggs for future use in assisted reproductive technology.

Condition	Intervention
Infertility	Device: Viacyte Media Kits

MedlinePlus related topics: Infertility

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Safety and Effectiveness of ViaCyte Freeze and Thaw Media Kits for the Manufactuing of Oocytes for Future Use in Assisted Reproductive Technology

Further study details as provided by ViaCell:

Primary Outcome Measures:

Live birth

Estimated Enrollment:	300
Study Start Date:	March 2007
Estimated Study Completion Date:	April 2009

Detailed Description:

ViaCyte is an investigational product intended to broaden reproductive options for women through freezing and thawing of human eggs. The egg is a large cell with a high water content, historically making it difficult to freeze. ViaCyte uses a choline chloride-based media designed to protect the cells from damage during the freezing process with the goal of making it possible to successfully store and thaw eggs for future use.

Following informed consent, female subjects will be screened according to the inclusion/exclusion criteria of the protocol and eligible subjects will undergo hormonal stimulation using standard IVF drugs.

Eligibility

Ages Eligible for Study:	21 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women 21-35 years of age
Women with male factor infertility seeking IVF treatment
Negative history of female infertility
Non-smoking for at least 1 year

Exclusion Criteria:

Greater than one miscarriage
More than one previous failed IVF attempt

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00451009

Locations

United States, California
Reproductive Science Center
San Ramon, California, United States, 94583
United States, Florida
South Florida Institute for Reproductive Medicine
South Miami, Florida, United States, 33143
United States, Iowa
University of Iowa Hospitals and Clinics, Center for Advanced Reproductive Care
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Boston IVF
Waltham, Massachusetts, United States, 02451

Sponsors and Collaborators

ViaCell

More Information

Study ID Numbers:	VRH-01
Study First Received:	March 20, 2007
Last Updated:	April 28, 2008
ClinicalTrials.gov Identifier:	NCT00451009
Health Authority:	United States: Food and Drug Administration

Keywords provided by ViaCell:

IVF
Male factor infertility
Cryopreservation
Cryoprotective agents
Egg Freezing

Study placed in the following topic categories:

Genital Diseases, Female
Infertility
Genital Diseases, Male

ClinicalTrials.gov processed this record on January 14, 2009